Cleared Traditional

K853710 - THERACUSHION (FDA 510(k) Clearance)

Class I Physical Medicine device.

K853710 · General Physiotherapy, Inc. · Physical Medicine device
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Jan 1986
Decision
120d
Days
Class 1
Risk

K853710 is an FDA 510(k) clearance for the THERACUSHION. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by General Physiotherapy, Inc. (St. Louis, US). The FDA issued a Cleared decision on January 3, 1986 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all General Physiotherapy, Inc. devices

Submission Details

510(k) Number K853710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1985
Decision Date January 03, 1986
Days to Decision 120 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 115d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ISA Massager, Therapeutic, Electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ISA Massager, Therapeutic, Electric

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